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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. / JOHNSON & JOHNSON MEDICAL ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC

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ETHICON, INC. / JOHNSON & JOHNSON MEDICAL ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PHY1520V
Device Problem Nonstandard Device (1420)
Patient Problems Fatigue (1849); Unspecified Infection (1930); Pain (1994); Hernia (2240); Abdominal Distention (2601); Constipation (3274)
Event Date 10/28/2011
Event Type  Injury  
Event Description

On (b)(6) 2011 i had an abdominal incisional hernia surgery at (b)(6) hospital, (b)(6). An ethicon physiomesh, model phy1520v was used. For the past 5+ years i have had many complications to include: severe pain; constipation, irritable bowel; severe bulging, distended stomach, abdominal infections, chronic fatigue, recurrence of hernia, potential malignancies and tumors, thinning of muscle walls; polycystic, kidney disease etc. All complications have been well documented by (b)(6) hosp, (b)(6). I have now learned that the ethicon mesh used was recalled. The ethicon recall notice advised that pts should inform the fda of serious problems. I now have serious problems at the age of (b)(6). I am now scheduled for another hernia surgery and i am informed by the surgery. Dr (b)(6), that there could be severe complications if the recalled mesh is removed.

 
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Brand NameETHICON PHYSIOMESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON, INC. / JOHNSON & JOHNSON MEDICAL
MDR Report Key8069177
MDR Text Key127198401
Report NumberMW5081196
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date04/30/2013
Device MODEL NumberPHY1520V
Device Catalogue NumberPHY1520V
Device LOT NumberDE8MGXAO
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/13/2018 Patient Sequence Number: 1
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